title: Understanding facilitators and barriers to reengineering the clinical research enterprise in community-based practice settings.
abstract: Solutions are employed to support clinical research trial tasks in community-based practice settings. Using the IT Implementation Framework (ITIF), an integrative framework intended to guide the synthesis of theoretical perspectives for planning multi-level interventions to enhance IT use, we sought to understand the barriers and facilitators to clinical research in community-based practice settings preliminary to implementing new informatics solutions for improving clinical research infrastructure. The studies were conducted in practices within the Columbia University Clinical Trials Network. A mixed-method approach, including surveys, interviews, time-motion studies, and observations was used. The data collected, which incorporates predisposing, enabling, and reinforcing factors in IT use, were analyzed according to each phase of ITIF. Themes identified in the first phase of ITIF were 1) processes and tools to support clinical trial research and 2) clinical research peripheral to patient care processes. Not all of the problems under these themes were found to be amenable to IT solutions. Using the multi-level orientation of the ITIF, we set forth strategies beyond IT solutions that can have an impact on reengineering clinical research tasks in practice-based settings. Developing strategies to target enabling and reinforcing factors, which focus on organizational factors, and the motivation of the practice at large to use IT solutions to integrate clinical research tasks with patient care processes, is most challenging. The ITIF should be used to consider both IT and non-IT solutions concurrently for reengineering of clinical research in community-based practice settings.
authors.affiliation: Department of Biomedical Informatics, Columbia University, New York, NY 10032, USA. rita.kukafka@dbmi.columbia.edu
authors.forename: Rita
authors.initials: R
authors.lastname: Kukafka
authors.forename: John P
authors.initials: JP
authors.lastname: Allegrante
authors.forename: Sharib
authors.initials: S
authors.lastname: Khan
authors.forename: J Thomas
authors.initials: JT
authors.lastname: Bigger
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Johnson
mesh_terms: D003153:Community Health Services / Q000458:organization & administration*; D003256:Community Participation / Q000379:methods; D006801:Humans; D007256:Information Systems / Q000458:organization & administration*; D011361:Professional Competence; D012107:Research Design
keywords: Clinical research; Clinical trials; Community-based practice; Informatics; Information technology